Location: Boston, MA
Company: Argenx
and 3rd parties. Represent the GPS Team in the backssment of vendor services outside of GPS that may have an impact on Pharmacovigilance. Use Contract Lifecycle Management System to obtain contract at right stage for backssment Manage and oversee the process of incorporating appropriate language into contractual agreements to clarify safety reporting expectations based on the scope of services provided and/or development, approval, execution, maintenance, and termination (when applicable) of PVAs.
Ensure that third party relevant safety reporting obligations and PVAs are adhered to. Provide training to relevant argenx employees and 3rd parties (when applicable) regarding PV contractual
obligations to gain a mutual understanding for expected deliverables and timelines of PV expectations for both parties In collaboration with the QPPV office, drive relevant planning, execution, and governance of PV contractual obligations in partnership with legal and appropriate GPS staff.
In collaboration with QPPV Office, responsible for alignment with Business Development, and participate in due diligence efforts Contribute to GPS, particularly, PVA process improvement initiatives Resolve vendor questions and escalate issues to relevant in-house GPS staff as appropriate. Provide regular vendor feedback to in-house GPS staff for inclusion into the Vendor Operational Governance Meetings
(when applicable). Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
Monitor compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff Provide input into the Pharmacovigilance System Master File as needed Perform other GPS Quality Management activities as needed Drive excellence into the business to reach optimal performance Engage and Co-create with stakeholders early on to do it right first time SKILLS AND COMPETENCIES Excellent planning and organizational skills Excellent oral and written communication skills Excellent presentation skills with the ability to communicate complex issues clearly Ability to work in global environment Demonstrated problem solving skills.
Work independently with ability to prioritize work and meet timelines Excellent presentation skills with the ability to communicate complex issues clearly Demonstrated ability to author and contribute to complex documents Ability to motivate, influence, and collaborate with multidisciplinary teams Excellent negotiation and networking skills Relevant computer skills, including proficiency with Microsoft Office Suite, experience with Veeva Systems, Contract lifecycle Management Systems (i Certis) is a plus Fluency in written and spoken English EDUCATION, EXPERIENCE AND QUALIFICATIONS Bachelor's or Master's degree in shop, nursing, healthcare or other life-scienceor technical field (Master's degree or Pharm D is a plus) At least 8 years of experience in the medical/biotech industry with at least 5years in pharmacovigilance/drug safety (global experience is a plus) Required knowledge of global PV laws and regulations Experience preferred in PV Contracts and vendor oversight Experience in GVP audit/inspection activities/process Excellent knowledge of drug development process, GXP quality and compliance requirements, global PV laws and regulations and GVP guidance documents At argenx we strive to create a welcoming and inclusive environment.
Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, interaction, interactionual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at xyz X@.
Only inquiries related to an accommodation request will receive a response. PDN-9af5c1ce2-bf00-d9fb7ac5febf
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